【摘要】 目的:建立注射用雷贝拉唑钠含量及有关物质的HPLC检测方法。方法:采用Shimadzu CLC-ODS不锈钢柱(150mm×4.6mm,5μm);流动相为磷酸盐缓冲液-乙腈(60∶40),流速1.0mL·min-1,检测波长为292nm。结果:雷贝拉唑钠与其相邻杂质峰能完全分离,雷贝拉唑钠在16.9～168.5μg·mL-1浓度范围内线性关系良好(r=0.9999),高、中、低3种不同浓度的回收率为99.0%～100.8%(n=9)。结论:本方法操作简便,精密度好,结果准确可靠,可用于该制剂的质量控制。更多还原

【Abstract】 Objective:To establish an HPLC method for the and determination of assay related substances of Rabeprazole Sodium for Injection。Methods:The chromatograph was equipped with a 150 mm×4.6 mm stainless column(model:Shimadzu CLC-ODS),with mobile phase of a mixture of phosphate buffer and acetonotrile(60∶40),flow rate of 1.0 mL·min-1and detection wavelength at 292 nm。Results:The data shows that this method can clearly separate Rabeprazole peak from its nearby impurity peaks,with a better linear range of 16.9-168.5 μg·mL-1(r=0.9999),and Rabeprazole Sodium average recovery range of 99.0% to 100.8% during tests in its high,middle and lower concentrations(n=9)。Conclusion:This method is simple,accurate and reliable,so it can be used for quality control of this preparation.更多还原